Job Description

5 days ago Be among the first 25 applicants Open market rate In person at ATO or remote (remote candidates must be especially exceptional with experience as the preference is onsite) Backfill- scrubbed resume attached Interview Process: To be considered, candidates MUST supply an online portfolio We will be holding a supplier call should resumes not align once shortlisted but hoping they are as we have sourced for this role over the past few years NOTE: This is expected to be a contract position within the Human Factors and Usability Engineering group, working 40 hrs/week. The position is for 1 year; it may be renewed at the end of that period. Ideally, candidates are local and work in-person in Thousand Oaks, CA. Exceptional candidate with successful experience working remotely may be considered. If candidate is within commuting distance to Thousand Oaks, they will be expected to work on-site most/all hours. There is no relocation for this position. Job Description: Supports the Instruction Design and Human Factors Engineering/Usability Engineering (HFE) teams to create instruction materials, including Instructions for Use (IFUs) used to instruct laypersons in the proper use of combination products/drug delivery devices. IFU creation includes copy, layout, and line-art illustrations. Develops both low- (simple sketch) and high-fidelity digital samples of instructional materials intended for print. Manages instruction design projects, working closely with other designers, HF engineers, and other related functions. Supports usability studies with quick turn-around during iterative studies in a design-test-refine-test model. Balances design thinking with regulatory requirements during development of instructional materials. Develops instructions for new projects by understanding user needs with HFE partners and applying platform guidelines to create approachable, useful, and effective instructions for users who may be new to the therapy and drug administration. Maintains history records to capture rationale for changes over the development of the instructions. Supports process improvement initiatives, including: defining and documenting current procedures within the group and working with cross-functional partners to improve and document labeling across upstream and downstream functions. Top Must-Have Skill Sets: Minimum 5-10 years of instruction design experience including IFUs, including strong proficiency in rapid sketch illustration, digital line-art illustration, and image (photo) editing. Proficient in Adobe Creative Suite (InDesign, Illustrator, Photoshop), and strong knowledge of InDesign paragraph and character styles. Understands the application of structure and grids for the development of platforms to ensure consistency in output and efficiency in process during instruction creation. Minimum 3-5 years managing design projects and/or teams. Medical, healthcare, medical devices and/or pharmaceuticals background. Must be punctual, reliable, flexible, and excellent at balancing multiple detail-oriented projects. If remote, must have experience working remotely from others in team. High-level attention to detail and accuracy in reducing errors in work deliverables. Day to Day Responsibilities: Create and update IFUs, reference guides, and carton artwork content and graphics (layout and illustrations) for new and existing medical device/combination products to ensure accuracy and compliance with applicable regulations, industry standards, and company requirements. Develop instruction design strategies for individual projects that align with department and corporate instruction platforms. Manage individual projects, representing the Instruction Design group, by coordinating with cross-functional teams (including Human Factors, Device Engineering, Marketing Labeling, Clinical, Legal and Regulatory Affairs) to define instructional requirements and execute on plans. Support extension of department platform designs into individual projects. Communicate daily with other designers on impact to platform designs, and update platforms as appropriate. Maintain change history of instruction materials during their development. Provide expertise and guidance to Human Factors engineering partners and other cross-functional partners with content generation, illustrations, layout, and formatting of instruction materials. Support process improvement programs and documentation of cross-functional processes. Manage junior staff and/or oversee external vendors to execute design work. Troubleshoot relatively complex problems and issues. Red Flags for Recruiters: Only academic experience Past experience exclusively in marketing, branding, logos, websites without any experience writing instructions for regulated products Only junior-level experience designing; we need senior-level experience and thinking for this role. Requires experience managing design projects and working with multiple stakeholders Text-based instructions only (ex., SOP development without illustrations and layout, personnel training manuals, defense user manuals) Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of experience OR Bachelor’s degree and 4 years of experience OR Associate’s degree and 8 years of experience OR High school diploma / GED and 10 years of experience Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at ALTEN by 2x Sign in to set job alerts for “Senior Human Factors Engineer” roles. UX Researcher - Hybrid - Santa Monica, CA (W2 Contract) Thousand Oaks, CA $65.00-$70.00 5 days ago Thousand Oaks, CA $45.00-$50.00 5 days ago Thousand Oaks, CA $50.00-$70.00 4 days ago Human Factors Engineer/Instructional Designer We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr ALTEN

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